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Table 3 Process Evaluation Elements

From: Healthy eating and lifestyle in pregnancy (HELP): a protocol for a cluster randomised trial to evaluate the effectiveness of a weight management intervention in pregnancy

Process evaluation component

Assessment

Context

• Data collected on a site proforma detailing site demographics, ethnicity, size, services delivered etc.

• Data on those delivering the intervention

• Data from two site observations completed at different time points in the intervention delivery period using a structured observation guide.

• Contextual issues explored in the staff focus groups and participant interviews

Reach

• Attendance at the group sessions

• Comparison of characteristics of those attending the intervention with those not attending

• Reach explored in the staff focus groups and participant interviews

Exposure

• Number of group sessions delivered

• Data from group session summary forms which describe those attending and the content/timings of sessions

• Data from site observations (two per site)

• Attendance at group sessions

• Exposure and attendance explored in the staff focus groups and participant interviews

• Data gathered on use of pedometers, step targets and walking diary completion

Fidelity

• Data from site observations (two per site)

• Data from group session summary forms which describes how the intervention was implemented at each session

• Fidelity explored in the staff focus groups and participant interviews

Recruitment

• Comparison of demographics of sites recruited

• Recruitment rates compared across sites in terms of how many recruited, who is recruited and also how quickly people are recruited

• Comparison of potentially eligible women with those recruited using data from case report forms and screening forms

• Recruitment issues explored in the staff focus groups and participant interviews

Retention

• Dropout by trial arm

• Dropout by site

• Comparison of demographics of those dropping out with those remaining

Contamination

• Participants asked what other services control group utilised in case report forms

• Contamination explored in the staff focus groups and participant interviews

Theory testing

• Mediation analyses using questionnaire data

• Theoretical mediators explored in the staff focus groups and participant interviews